Ropeginterferon alfa-2b-njft Approved for Polycythemia Vera

The U.S. Food and Drug Administration (FDA) has approved ropeginterferon alfa-2b-njft for the treatment of adult patients with polycythemia vera (PV).

This decision is based on safety data from the PEGINVERA and PROUD/CONTINUATION-PV studies and efficacy data from the PEGINVERA trial. After 7.5 years of treatment with ropeginterferon alfa-2b-njft, 61% of patients with PV experienced complete hematologic response (defined as hematocrit <45% without phlebotomy for at least two months, platelets ≤ 400 × 109/L, leukocytes ≤10 × 109/L, and normal spleen size). In addition, 80% of patients achieved hematologic response according to objective laboratory parameters.

The most common adverse events, occurring in >40% of patients, included influenza-like illness, arthralgia, fatigue, pruritis, nasopharyngitis, and musculoskeletal pain. Serious adverse events occurring in >4% of participants were urinary tract infection, transient ischemic attack, and depression.

Monopegylated long-acting interferon ropeginterferon alfa-2b-njft exhibits its cellular effects on PV in the bone marrow, according to a manufacturer press release. Its pegylation technology has a long duration of activity in the body and is aimed to be administered once every two weeks or longer until hematologic parameters are stabilized, allowing flexible dosing to meet the individual needs of patients. After one year, patients with stable complete hematologic response (CHR) can be treated every four weeks. The approval heralds a new paradigm in the treatment of PV by impacting the long-term outlook of this disease.

Ropeginterferon alfa-2b-njft carries a boxed warning for aggravation of neuropsychiatric, autoimmune, and ischemic disorders as well as infections.

Source: PharmaEssentia Corporation press release, November 12, 2021.